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ABASAGLAR 100 units/mL solution for injection in cartridge & pre-filled pen

Last Updated on eMC 24-Feb-2017 View document  | Eli Lilly and Company Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 24-Feb-2017 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 19-Jan-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



New text is underlined in bold, removed text is struckthough in bold.

 

Changes

 

4.         CLINICAL PARTICULARS

4.2      Posology and method of administration

 

……

Transition Switch from other insulins to ABASAGLAR

When changing switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with ABASAGLAR, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products).

 

Switch from twice daily NPH insulin to ABASAGLAR

To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with ABASAGLAR should reduce their daily dose of basal insulin by 20-30 % during the first weeks of treatment.

 

Switch from insulin glargine 300 units/ml to ABASAGLAR

ABASAGLAR and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly interchangeable. To reduce the risk of hypoglycemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with ABASAGLAR should reduce their dose by approximately 20%.

 

During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually.

 

As with other insulin analogues, patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with ABASAGLAR.

 

Close metabolic monitoring is recommended during the transition switch and in the initial weeks thereafter.

With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypoglycaemia or hyperglycaemia (see section 4.4).

 

Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with ABASAGLAR.

 

………..

 

4.4       Special warnings and precautions for use

 

……….

Pens to be used with ABASAGLAR cartridges

 

The cartridges should only be used in conjunction with a Lilly reusable insulin pen recommended for the use with Lilly insulin cartridges and should not be used with any other reusable pen as the dosing accuracy has not been established with other pens.

………..

 

6.         PHARMACEUTICAL PARTICULARS

6.6          Special precautions for disposal and other handling

 

ABASAGLAR must not be mixed with any other insulin or medicinal products or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.

 

Insulin pen

 

The ABASAGLAR cartridges are to be used only in conjunction with a Lilly reusable insulin pen recommended for the use with Lilly insulin cartridges (see section 4.4).

 

The pen should be used as recommended in the information provided bywith the device manufacturer.

 

The manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the needle, and administering the insulin injection.

 

If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.

 

If the pen malfunctions (see instructions for using the pen), the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 units/mL) and injected.

 

It is important to ensure that syringes do not contain traces of any other material.

 

 ………….

 

10.          DATE OF REVISION OF THE TEXT

 

19 January 2017

Updated on 17-Jul-2015 and displayed until 24-Feb-2017

Reasons for adding or updating:

  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 21-May-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Addition of new marketing authorisation numbers for 80 unit pre-filled pens.

 

8.             MARKETING AUTHORISATION NUMBER(S)

 

Cartridges

EU/1/14/944/001                                Pack of 1 cartridge

EU/1/14/944/002                                Pack of 2 cartridges

EU/1/14/944/003                                Pack of 5 cartridges

EU/1/14/944/004                                Pack of 10 (2 x 5) cartridges

EU/1/14/944/009                                Pack of 10 (2 x 5) cartridges

 

Pre‑filled pens (60 Units)  

EU/1/14/944/005                                Pack of 1 pre-filled pen

EU/1/14/944/006                                Pack of 2 pre-filled pens

EU/1/14/944/007                                Pack of 5 pre-filled pens

EU/1/14/944/008                                Pack of 10 (2 x 5) pre-filled pens

 

 

Pre‑filled pens (80 Units)  

EU/1/14/944/010                                Pack of 1 pre-filled pen

EU/1/14/944/011                                Pack of 2 pre-filled pens

EU/1/14/944/012                                Pack of 5 pre-filled pens

EU/1/14/944/013                                Pack of 10 (2 x 5) pre-filled pens

 

 

10.          DATE OF REVISION OF THE TEXT

 

21 May 2015

Updated on 26-Jun-2015 and displayed until 17-Jul-2015

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): YES

Company contact details

Eli Lilly and Company Limited

Company image
Address

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL

Fax

+44 (0)1256 775 858

Medical Information Fax

+44 (0)1256 775 569

Telephone

+44 (0)1256 315 000

Medical Information e-mail

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

insulin glargine

Legal categories

POM - Prescription Only Medicine

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